Standardized measurement of physiological pressures using an air-charged catheter apparatus

Inventors

Damaser, Margot S.Awada, Hassan K.Fletter, Paul C.Cooper, MitchellZaszczurynski, Paul J.

Assignees

Cleveland Clinic FoundationUS Department of Veterans Affairs

Publication Number

US-11957468-B2

Publication Date

2024-04-16

Expiration Date

2032-09-21

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Abstract

Systems and methods are provided for providing a standardized pressure value representing a transient pressure event within a region of interest within a living body. An air-charged catheter is configured to record pressure data representing the region of interest. A measurement assembly includes a parameter calculation component configured to calculate at least a peak pressure representing the transient pressure event and a time to peak pressure, representing the time necessary to reach the peak pressure, from the recorded pressure data. A standardization component is configured to calculate the standardized pressure value as a function of the peak pressure and the time to peak pressure. A user interface is configured to display at least the standardized pressure value at an associated display.

Core Innovation

The invention provides systems and methods for generating a standardized pressure value that represents a transient pressure event within a region of interest inside a living body using an air-charged pressure sensing catheter. The air-charged catheter records pressure data from the target region, and a measurement assembly calculates parameters including peak pressure and time to peak pressure from this data. A standardization component then computes a standardized pressure value as a function of both the peak pressure and the time to peak pressure. This standardized pressure is displayed to the operator, facilitating interpretation of the measurement.

The problem addressed arises from the differing pressure response characteristics of air-charged catheters compared to traditional water-filled or microtip catheters. Air-charged catheters exhibit an overdamped response with a slight delay, leading to underestimation of peak pressure during transient pressure events. Since many diagnostic standards and clinical values have been developed using other catheter types, direct comparison and clinical interpretation of air-charged catheter readings have been challenging. The invention solves this by standardizing the air-charged catheter pressure data to correspond to expected values from water-filled catheters.

The method includes inserting the air-charged catheter into the region of interest, collecting pressure data that includes a transient event (such as coughing or sneezing), and determining a baseline and peak pressure from the data. The time to peak pressure is measured from 5% of the peak pressure rise to the peak itself. The standardized pressure is calculated as the product of the peak pressure and a function involving the time to peak pressure, thus compensating for the response delay inherent in air-charged catheters. This approach allows for standardized, comparable pressure measurements across catheter types.

Claims Coverage

The patent includes two independent claims covering methods and a non-transitory computer readable medium for standardized pressure measurement using air-charged catheters. The main inventive features relate to the calculation and use of standardized pressure values compensating for the unique response characteristics of air-charged catheters.

Method for recording standardized pressure with an air-charged catheter

A method comprising inserting an air-charged catheter into a region of interest, collecting pressure data during a transient pressure event, determining peak pressure as the difference between maximum and baseline pressure, calculating a standardized pressure as a function of the determined peak pressure that represents a value expected for a water-filled catheter, and displaying this standardized pressure to an operator.

Calculation of time to peak pressure for enhanced standardization

Determining time to peak pressure as the duration for pressure to rise from five percent of maximum to maximum pressure, and calculating the standardized pressure as a function of both the peak pressure and the time to peak pressure, improving accuracy of the standardized measurement.

Non-transitory computer readable medium for standardized pressure calculation

Machine executable instructions stored on a computer readable medium that determine peak pressure and time to peak pressure from pressure data collected by an air-charged catheter and calculate a standardized pressure value representing the expected peak pressure of a water-filled catheter using a specific formula involving these parameters.

These inventive features collectively provide a standardized approach to interpreting transient pressure measurements obtained via air-charged catheters by compensating for their overdamped response properties through peak pressure and time to peak pressure analysis, enabling consistent and clinically meaningful pressure values.

Stated Advantages

Air-charged catheters are relatively inexpensive, easy to use, disposable, and significantly less subject to artifact compared to traditional catheter technologies.

The system provides standardized pressure values consistent with values from water-filled catheters, facilitating clinical interpretation and comparison.

The method accounts for the overdamped nature of air-charged catheters by incorporating time to peak pressure in the standardization calculation, improving measurement accuracy.

Documented Applications

Measuring pressures within the urethra, bladder, or rectum regions during transient events such as coughing, sneezing, or Valsalva maneuvers in urological applications.

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